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All posts for the month August, 2015

New research finds interoperability capabilities in EHRs evolving too slowly

BOSTON | July 28, 2015

The most valued patient data resides in the EHR, yet EHRs are architected to perpetuate data silos. Because of the lack of interoperability, healthcare providers can’t achieve true care coordination.

To date, EHR vendors have turned a blind eye to this critical flaw, and according to a new report from Boston-based Chilmark Research, there is no sign they will change anytime soon.

The rapid expansion of value-based reimbursement is exposing unmet needs for active coordination – care, financial and administrative – within and between healthcare organizations, say Chilmark executives in a news release announcing the findings.

“Most EHR vendors regard their core clinical systems as comprehensive and inviolable – few readily admit that provider needs are have long outstripped existing EHR feature sets and ongoing development efforts,” Chilmark researchers conclude in the report.

At the same time, they note, healthcare end-users have elevated expectations based on consumer-facing application ecosystems or “app stores” – built on the technical foundation of open APIs in a cloud-based environment.

The EHR market is ripe for the development of an application ecosystem to rapidly extend functional capabilities and remedy usability deficiencies, they say. But first it needs open APIs and a Platform-as-a-Service for developers.

The research found that independent software vendors have mixed opinions about the capabilities offered by EHR vendors.

“Some survive, and even thrive, but always at the sufferance of major EHR vendors,” the report asserts. “Others survive in the shadows, taking pains not to attract any attention from EHR vendors for fear of being shut out.”

The report characterizes the interoperability capabilities of prominent EHR vendors. Current technology interfaces that provide data after the fact, non-disclosure agreements, data access fees, and the lack of reasonable software tools for developers are all obstacles to the development of extensions for developers.

Open APIs as solution

The report describes how the leading candidate for open APIs in healthcare – HL7 Fast Healthcare Interoperability Resources, or FHIR – is being implemented by EHR vendors. This new technology offers the most potential to provide real-time access to data across applications and organizations and may ultimately give rise to Platform as a Service-based ecosystems, according to Chilmark Research analyst Brian Murphy, lead author of the report.

“Open APIs will ultimately form the basis for the interoperable health records that patients and providers are demanding,” Murphy said in a statement. “The work being done by the major vendors to support FHIR is only the beginning. In the next year, we expect healthcare technology contributors – IT vendors, payers, health information organizations and others to move beyond endorsement to actual implementations.”

As Murphy sees it, FHIR APIs will eventually replace much of the data exchange technology painstakingly assembled over the last 30 years with modern ideas of open, distributed computing. Programmers will access data where it lives rather than where it has been staged, leading to rapid improvements in IT functionality, usability and genuine choice in applications to use.

The report concludes that the healthcare market is “quite ready” for API-driven extensions to clinical and financial applications.

Leading IT vendors will need to API-enable their core products if they wish to foster a PaaS ecosystem that accelerates their ability to address unmet needs of end users, Murphy concludes.

“EHR vendors are better positioned than any other HIT vendors to become true platform vendors as they are still at the center of physician workflow, hold the keys to clinical patient data, and still command the lion’s share of IT resources and subsequently attention from HCO C-suites,” he says. “This is their opportunity to lose if they fail to innovatively create a true ecosystem around their offering.”

The report provides a snapshot of several EHR vendors’ interoperability capabilities, or lack thereof, as well as a review of their nascent API programs.

A similar report, to be published in late 2015, will provide a similar analysis of what other IT vendors serving the healthcare sector are doing to enable their own PaaS strategy. This second report will also include an analysis of how other well-known providers of interoperability solutions (i.e. CommonWell and the Sequoia Project (formerly HealtheWay)) are contributing to the development of a more platform-centric approach that can deliver an application ecosystem to healthcare.

The Pentagon today awarded its years-in-the-making multibillion contract to upgrade its electronic health records system, to defense IT firm Leidos, which partnered with electronic health record vendor Cerner and Accenture Federal.

The Defense Healthcare Management Systems Modernization contract’s base value is $4.3 billion over 10 years, with an expected 18-year lifecycle value of $9 billion, and will put Leidos in charge of building a next-generation health records system responsible for DOD’s 9.6 million beneficiaries.

Eventually, the software will be deployed at more than 1,200 sites and across 56 inpatient hospitals and medical centers. The final cost estimate is down from the initial $11 billion over the project’s life cycle.

In a briefing with reporters Wednesday morning, Frank Kendall, undersecretary of defense for acquisition, technology and logistics, called the contract award an “important step in the acquisition of a modern health care system for DOD.”

“It’s not the final step by any means; we have a lot of work ahead of us, but this is the culmination of two years of work to get here,” he said. “We have taken the time to do this job right.”

The highly competitive contract initially saw six initial bids narrowed down to three by February: IBM and partner Epic Systems; Computer Sciences Corp., with HP and EHR developer Allscripts; and the Leidos-led team all in the running.

Work under the contract, which DOD began conceptualizing in 2013, will begin with deploying and field testing software to ensure its security and operational capabilities across eight locations in the Pacific Northwest by the end of 2016. DOD’s target, Kendall said, is to have the health records platform “interoperable and running” across all sites by 2022.

“That’s our baseline,” he said. “We are going to refine that based on the award and initial technical discussion. We’d like to go more quickly.”

Kendall, speaking alongside Dr. Jonathan Woodson, assistant secretary of defense for health affairs, and Chris Miller, the program executive officer of the Defense Healthcare Management Systems, said the contract award took in consideration both interoperability and cybersecurity.

Miller acknowledged public and congressional criticism in recent years over an inability for the current DOD health records systems to share health records with the Department of Veterans Affairs. DOD’s current health records systems, the Armed Forces Health Longitudinal Technology Application, or AHLTA, was developed by Leidos when it was known as SAIC.

Miller said DOD will “comprehensively test the product” and dig “deep into security and interoperability both with VA and the private sector” before deploying it. He told reporters DOD and VA have made major interoperability improvements over the past two years.

“The DOD and VA are interoperable today electronically,” Kendall said. “We send over a million pieces of data a day to VA. We have interoperability we’ll be certifying to the Congress here very shortly. We want to sustain that and enhance that with this new system.”

Kendall said DOD wants interoperability not only with VA but also with commercial providers. “Interoperability was a fundamental consideration,” he added.

The Pentagon is also concerned about cybersecurity, he said.

“We wanted to make sure we took adequate steps to protect the information that will be on this system, as well as the privacy of health care information,” Kendall told reporters.

In a statement, Leidos spokeswoman Jennifer Gephart said the company is “honored” to work on the contract.

“Our team stands ready to lean forward with the DOD to implement a world class electronic health records system,” she said.

When reached for comment, both competing systems integrators also provided Nextgov comment.

“Today, CSC learned of DOD’s decision regarding the Defense Healthcare Management System Modernization contract award,” said CSC spokesperson Heather Williams. “While this is not the outcome we anticipated, we’ll receive a debrief and evaluate our options.”

IBM spokesperson Clint Roswell told Nextgov: “We are very disappointed by today’s announcement and firmly believe that our proposal, along with our combined expertise, would provide the U.S. Department of Defense with the most innovative technology platform to best serve our military families now and into the future.”

He added, “We stand ready to help the Defense Department in this endeavor.”

Either company could potentially file a bid protest within 10 days of the contract award. Bid protests are not uncommon with contracts of this magnitude – the scope of the deal is on par with some of DOD’s weapons systems – but Kendall said if a protest is filed, he believes DOD followed the rules.

“We think we’re in a good position; we followed the rules put in place,” said Kendall, noting DOD had “viable bidders in the end” that resulted in “a clear best-value solution for us.”

“We’re hoping there is not a protest,” Kendall said. “We’re prepared to deal with it if there is.”

We’re currently witnessing an explosion of digital health applications and software that is producing rapidly growing volumes of consumer and patient information. As a result, healthcare organizations are sitting on large stores of data that have significant value beyond the primary clinical use for which it was collected.

This data, shared responsibly, can be used to help solve some of healthcare’s most challenging problems. It can play a critical role in driving innovative research, deriving key insights and gaining new knowledge that can lead to faster and better treatments and cures for a wide range of health conditions and diseases. Other uses of the data include clinical trials transparency, quality and safety measurement, public health, payment, provider certification or accreditation, marketing, and other business applications.

For many of these uses, the data may be monetized by data custodians. Data monetization is exactly what it sounds like – making money by selling the data to another organization, or selling reports based on the data. The simple truth is our personal information is being collected, analyzed, bought, and sold on an increasingly routine basis. According to Gartner, 30 percent of all businesses will be monetizing their information assets by 2016.

Safely Managing Health Data Monetization

A large number of health and healthcare organizations share and monetize data. They include federal and state public health agencies, pharmaceutical companies, hospitals and healthcare providers, academic medical centers, cancer and birth registries, medical device manufacturers, insurance companies, EMR vendors, and health information exchange organizations.

Health data cannot, and should not, be sold or exchanged without proper consideration into what it will be used for. And it’s necessary to understand what personal identifiers exist in the data to know what could put individual patient privacy at risk.

The HIPAA Privacy Rule, by establishing national standards, requires safeguards to protect personal health information and sets conditions on how it is used. The Health Information Technology for Economic and Clinical Health (HITECH) Act strengthened the enforcement of HIPAA. It requires authorization from each individual in a data set for any sale of Protected Health Information (PHI). While this addresses important privacy concerns, it’s not always possible for health organizations to secure consent from each individual in a large data set – because they’ve moved, trauma or sensitivity of the event, or are deceased – and unless all patients consent the results of any analysis may be put into question.

Unable to sell PHI without the consent of all patients, research efforts could be severely hampered. However, there is a way to achieve HIPAA compliance, share and monetize data, and still protect patient privacy. Under HIPAA, properly de-identified data is no longer considered PHI and therefore can be shared and monetized without consent.

There are two general approaches to de-identification, the “list” approach and the “statistical” approach, exemplified by the methods stipulated in the HIPAA Privacy Rule: Safe Harbor and Expert Determination. Safe Harbor specifies 18 elements that need to be removed or modified – 16 of those are direct identifiers, such as name and social security number, while two are quasi-identifiers that provide elements of dates or geography. Safe Harbor also includes a caveat that requires there be no clear or direct knowledge that anything else in the data could be used to re-identify individuals.

Whereas Safe Harbor is a one-size-fits all approach, Expert Determination requires an assessment of risk given a specific context. Based on the level of risk, direct identifiers and quasi-identifiers can be removed or modified so that the data retains value for research and analysis.

It’s important to note that proper data de-identification is not the same as data masking. While commonly used masking techniques hide or remove direct identifiers, this still leaves risk from the quasi-identifiers. There is legal risk for non-compliance with HIPAA, financial risk from fines and lawsuits due to a data breach, and the reputational risk of losing patient trust when they learn that PHI was being shared or monetized inappropriately. Not to mention that masking to remove PHI can strip away the value of the data, rendering it less useful for research and analysis, and therefore a less valuable commodity for monetary gain.

Only one of these methods provides the most utility and value of the data while still protecting privacy, and that is de-identification. The de-identification of data is more sophisticated and leads to better results because responsible expert determination methodology and tools are used to manage the risks associated with the specific use of the data. Legal compliance is also satisfied when consistent de-identification standards and effective risk management procedures are used to protect patient privacy.

For data to be considered de-identified, the context of the data release is analyzed through a risk assessment. This assessment analyzes the type and content of the data, what type of organization is receiving the data and how they will use it, as well as how the data will be protected through physical and policy measures. All these factors are considered to determine the risk of re-identification, and the data is then adjusted accordingly to provide a data set with the lowest level of risk for the highest level of use. Remember, once the data is no longer considered PHI, it is no longer covered under HIPAA.

As demand for data sharing and monetization grows, so do concerns about privacy and risk. The good news is that privacy can be easily addressed by using the right approach. Responsible de-identification is a reputable, HIPAA-compliant solution to safely monetizing the data that health and healthcare organizations have at their disposal.

Rudy Richman is the Vice President of Sales and Marketing for Privacy Analytics, where he is responsible for the development, implementation and execution of strategies that deliver expert determination de-identification methodology and products to the marketplace. He uses his extensive market knowledge, business experience and leadership skills to design multi-faceted programs and provide strategic guidance to both established and emerging companies in technology, healthcare and other industries seeking to efficiently scale and monetize their assets.

Veterans Affairs Department Secretary Bob McDonald voiced his support for open source technology July 30, as he outlined a broad reform plan that includes streamlining information technology and taking a more “holistic” look at customer service.

“We have over 200 databases with customer information. That means if you want to change your address, you have to go to at least nine places to change your address at VA,” said McDonald during a morning keynote July 30 at a conference in Bethesda, Md.

“We want to go to one data backbone, one data inventory,” he said.

McDonald also lamented that the department has 900 1-800 phone numbers for veterans. He’d like to consolidate that down to a single contact line.

McDonald told attendees at the OSERHA Open Source Summit that VA also has hundreds of websites – 14 of which require a username and password login for vets.

“We’re going to be going to a unified digital experience for all veterans,” said McDonald.

All of these digital technologies will be open source, he added.

“There’s no other way to operate in our opinion than open source. And we’re counting on all of you to make that happen. We’re going to be open source and we want to have crowd-sourced innovation,” said McDonald.

“PrecisionFDA will supply an environment where the community can test, pilot, and validate new approaches.”

August 5, 2015

The U.S. Food and Drug Administration on Wednesday revealed that it is working to build a software platform for precision medicine and an informatics community around it.

FDA’s Office of Health Informatics, in fact, contracted with DNAnexus, to create open source cloud-based software for sharing genomic information.

Dubbed precisionFDA, the platform can be used to evaluate bioinformatics workflows and essentially crowdsource reference data sets, according to DNAnexus, which describes itself as a cloud-based genome informatics and data management company.

President Obama’s Precision Medicine Initiative will necessitate that fashion of collaboration, Taha Kass-Hout, MD, FDA’s chief health informatics officer and FDA policy advisor David Litwack wrote in a blog post.

“To begin to realize this new vision, precisionFDA is designed to develop the necessary standards. PrecisionFDA will supply an environment where the community can test, pilot, and validate new approaches,” Kass-Hout and Litwack wrote, providing as example of the opportunity for developers, research, and others to not only share but also cross-validate test results against reference materials.

When the precisionFDA beta opens, slated for December of 2015, users will be able to access independent work areas for software code or data that can either be kept private or shared with whomever the contributor chooses. The public space will host tools including a wiki, open access reference genomic data models and analytics.

“We believe precisionFDA will help us advance the science around the accuracy and reproducibility of next generation sequencing-based tests, and in doing so, will advance consumer safety,” Kass-Hout and Litwack noted.

It is only after a revolution concludes that one can clearly look back and fully understand what triggered the revolution. External factors such as technology shifts can create the conditions for a revolution where it may not have been possible before. A generation that has a different worldview than their elders may not accept that status quo. From what I’m observing, I believe we are seeing a revolution’s first phase happen before our eyes.

I’m convinced that the only way there will be a true revolution in healthcare is if there is a partnership between clinicians and individual citizens (aka patients/consumers/people). One without the other isn’t sufficient to unseat deeply entrenched systems. However, I feel doctors will play a unique role in catalyzing the revolution (not to say that clinicians of all types won’t play important roles as well). As I’ve been a Johnny Appleseed of sorts chronicling the far-reaching and transformational work of doc-entrepreneurs, it feeds my optimism that it’s possible to overcome the “Preservatives” who have 3 trillion reasons to protect the status quo.

For those of us who have seen how much better the system can work when goals are properly aligned, it’s “good news” that doctor burnout and dissatisfaction is at an all-time high (see The Quadruple Aim: A Square Deal for Clinicians for more). Why? Dissatisfaction is the seed corn for change and revolution. Make no mistake. There is extremely high level of dissatisfaction amongst a large chunk of doctors who yearn for change. The contrast between those inside of flawed versus optimized care delivery and payment models is stark. One the one hand, I have heard and seen docs who are seeing 30-50 patients a day, dealing with unwieldy/outdated EHRs optimized for billing (vs. care) and getting more bureaucracy thrown on top of an already-flawed model. On the other hand, it’s breathtaking when I visit clinics like CareMore, ChenMed, Iora Health, Qliance, Vera Whole Health and others where the clinicians and patients are both extremely satisfied.

In the video below, Dr. Zubin Damania powerfully captures the sorts of internal dialogue doctors have had one by one with themselves.

When people would talk about their careers or their lives, the ones that were most passionate and were loving what they did always aroused in me an unease. It was almost an anger or jealousy and I would see them and go, “Why is he so happy and fulfilled and doing what he loves to do and I’m doing everything I’m supposed to do but I feel empty?” On the other side of this waking up and being who I am suddenly, I felt like, “Oh my god, that’s me now.”

I suspect all the doctor entrepreneurs/leaders I’ve highlighted below had some similar internal discussions. This is how revolutions begin. By no means is it limited to young doctors but typically it’s the young who foment revolutions and they are then joined by those older than them. As you can see in the picture accompanying this article after the post-Velvet Revolution celebration, it’s all ages who celebrate. It’s worth noting that the Velvet Revolution was triggered by a crackdown on students.

Harvard Medical School students stage a die-in. Photo from Tamara Rodriguez Reichberg, Harvard Medical School student

Skeptics may say that these revolutionary practice models are a drop in the bucket and in most places, it’s business as usual. That is true just as it was true that the newspaper business looked fantastic in the late 1990s and early 2000s while digital media was going from tiny to small. However, the mistakes made by newspapers and their Zero Sum Game thinking were happening simultaneous to startups getting funding that would ultimately crush the most profitable portions of the newspaper business, not to mention create new sectors far bigger than the newspaper industry. Sadly (for the newspapers), they could have owned, invested or partnered with these players yet most arrogantly dismissed them.

Those startups were easy to ignore or diminish just as incumbent providers are blind to the exponential growth and funding (figures in parentheses) that organizations such as Aledade ($34.5M), Alignment Healthcare ($125M), Iora Health ($48.3M) and One Medical ($116.5M) are receiving. Further, other revolutionary organizations have already been acquired. CareMore was acquired for $800M by WellPoint and and HealthCare Partners was acquired for $4.4B by DaVita. It’s worth noting that the acquisitions weren’t by traditional providers. Rather, it was deep-pocketed players seeing an easy mark in soft oligopolistic health systems.

Not unlike digital media startups of the late 1990s and early 2000s, the next generation care delivery organizations are focused on adding value and scaling their business and not particularly focused on the incumbent organizations. Yet, the byproduct of their rapid growth and optimization is they devastate the incumbent’s bread and butter business. One of those CEOs of the aforementioned organizations said they observe that at least 50% of the care their patients had been receiving before moving into their model was waste. Or worse, it was harmful. In other words, it’s like shooting fish in a barrel to remove the waste while improving outcomes. They reduce hospital days, ER visits and unnecessary surgeries by nipping issues in the bud before they blow up. Note that each of those items are the profitable lines of business for health systems.

Change Starts at Home

Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has. – Margaret Mead

I put my family where my mouth is and convinced my folks to move into one of these revolutionary practices. They had been going to a well-regarded, large multi-specialty group in Seattle. However, the care they got was typical of our misaligned healthcare system. When my father was diagnosed with a significant chronic condition, he received a couple prescriptions from a specialist and told to check back in 6 months with the doctor. His PCP had no idea he’d been diagnosed with a significant condition. Meanwhile, his world came crashing down and a huge amount of anxiety and stress was thrust on him — surely, not the best “prescription” for his condition.

While it’s rarely easy to get someone to change their doctor, let alone a senior who has a significant condition, I ultimately prevailed in convincing my parents to make the move. Six months into being in Iora Health’s Medicare Advantage program, the change is dramatic. So much so that my dad told me last weekend he’d be happy to be a testimonial for them.

Creating the New Ecosystem

You never change things by fighting the existing reality. To change something, build a new model that makes the existing model obsolete. Buckminster Fuller

In their own way, each of the doctors listed below is contributing to building the new ecosystem and ignoring the Preservatives who are wedded to the status quo. As mentioned above, there are non-physician clinicians and individual citizens having a big impact but I focus on doc-entrepreneurs and intrapreneurs here.

Dr. Rajaie Batniji co-founded Collective Health in the belief they could help employees receive better care and coverage than what many experience with incumbent health plans

The late Dr. Tom Ferguson coined the term e-patient many years before others were focused on equipped, enabled, empowered and engaged patients. This is a whitepaper (PDF) finished by his colleagues after his untimely passing.

Dr. Paul Grundy has led IBM’s transformation in healthcare shifting their thinking from healthcare as a soft benefits item left to HR to something that is a critical supply chain cost and source of competitive advantage.

Dr. Farzad Mostashari described Aledade’s goals as follows: ”It’s to help independent primary care doctors re-design their practices, and re-magine their future. It’s to put primary care back in control of health care, with 21st century data analytics and technology tools. It’s to support them with people who will stand beside them, with no interests other than theirs in mind.”

Dr. Stan Schwartz saw what Dr. Keith Smith was doing and has been creating a true transparent medical network and making that available to employers — both doctors and patients are saved from excruciating amounts of bureaucracy in a very appealing economic model to both parties. It’s also the first Health Rosetta item to be delineated.

Four years ago, I observed how doctors such as Wendy Sue Swanson, Natasha Burgert & Howard Luks were doing something similar to how Sal Khan had “flipped the classroom”. This led to the Robert Wood Johnson Foundation initiating a major program called Flip the Clinic to improve outcomes and participation by patients.

Dr. Eric Topol has written and spoken extensively about how central the patient will be as a participant in their care compared to traditional practices. He highlights how the smartphone is the equivalent of the Gutenberg Press for medicine

Dr. Bryan Vartabedian is showing other doctors how to be a “public” physician & the impact that can have on outcomes

By no means is the list above complete. Add your comment below on a revolutionary doctor that has inspired you. Let us know what they are doing. Whether it is private practice, venture-backed startups, public health or health benefits, each doctor is contributing to the revolution. In their own way, they are fostering a Velvet Medical Revolution.